Terms and Conditions
1. BASIS OF CONTRACT FOR SUPPLY. Leiters shall Supply to Customer, and Customer shall purchase from Leiters, Product(s) in accordance with these Conditions, to the exclusion of all other terms and conditions (whether of Customer or otherwise). No order submitted by Customer shall be deemed to be accepted by Leiters, no Contract for Supply shall exist, and no obligation or commitment of Leiters shall arise, whether in respect of any quotation by Leiters or otherwise, unless and until an order submitted by Customer is acknowledged, confirmed, filled or otherwise accepted by Leiters, whereupon a Contract incorporating these Conditions shall exist. Unless otherwise agreed in Writing, Leiters shall have no obligation to accept any order submitted by Customer. No Special Terms or any other variation to these Conditions or any applicable Contract shall be binding upon Leiters unless agreed to in Writing between Customer and Leiters, and any Special Terms so agreed upon which contradict these Conditions shall prevail over these Conditions. Definitions of capitalized terms are set forth at the end of these Conditions.
2. QUOTATIONS AND PRICES. Any quotation given by Leiters incorporates these Conditions. The price of the Supply of Product(s) shall be Leiters’ price in any relevant quotation or, where no price has been quoted (or a quoted price is no longer valid), the price listed in Leiters’ published price list existing on the date of Leiters’ acceptance of Customer’s order. Unless otherwise agreed in Writing, Leiters reserves the right to adjust the price of its Products in its sole discretion from time to time, including without limitation to cover any increases in its cost to Supply. The Parties acknowledge that the prices under these Conditions and/or the Contract may reflect discounts, rebates, or other reductions in price (collectively, “discounts”), and it is their intention that such discounts shall be administered consistent with the discount exception to the federal anti-kickback statute (42 USC 1320a-7b(B)(3)(A)) and the related regulatory discount safe harbor (42 CFR 1001.952(h)). Leiters will reflect when a discount applies on invoices or alternative document, and Customer may request additional documentation of purchases and discounts hereunder as necessary to facilitate appropriate reporting. To the extent and as required by Applicable Laws or other contractual obligations, it is Customer’s responsibility to appropriately report or reflect such discounts, including any bundled discounts, on cost reports or claims submitted to third party payors, including but not limited to federal or state health care programs. Further, Customer will retain documentation provided by Leiters relating to purchases and discounts hereunder and make it available to federal or state health care program representatives upon request.
3. COMPONENTS. If any component of compounding, repackaging, or other Supply services is to be supplied to Leiters by Customer or Customer’s distributor or supplier of such component (for example, Avastin®), then: (a) any such component that is itself an approved finished human drug product (i) shall have been purchased either (A) directly from a manufacturer who has registered and is listed with FDA under Section 510 of the Act, without repacking or other alteration since initial manufacture, or (B) from a distributor that certifies that such component has not been subject to repacking or other alteration since initial manufacture, and (ii) shall have been stored in compliance with, and shipped to Leiters under conditions that comply with, all labeling specifications and requirements for such component; (b) such component shall be delivered to Leiters FOB the Facility; (c) Customer (or, if applicable, Customer’s distributor or supplier) shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping such component to the Facility and shall bear all risk of loss of or damage to such component while in transit; (d) Leiters reserves the right, without notice, to reject such component and return it to Customer, at Customer’s sole expense (or, if applicable, to Customer’s distributor or supplier at such distributor’s or supplier’s sole expense) and without liability to Leiters, if such component fails to comply with or satisfy any requirement of clause (a) above or if the expiration date or beyond-use-date of any such component is insufficient to allow the Product that is to be Supplied by Leiters to have an expiration date or beyond-use-date that complies with Applicable Laws or the applicable Leiters Standard Operating Procedures for quality and dating of such Product; and (e) excess quantities of such component (if any) shall become the property and responsibility of Leiters to be used and/or disposed of by Leiters in its sole discretion without remuneration to Customer (but in any case in compliance with Applicable Laws). If any component of compounding, repackaging, or other Supply services is itself an approved finished human drug product (for example, Avastin®) that is required for such Supply services and is not to be supplied to Leiters by Customer or Customer’s distributor or supplier of such component: (x) Leiters will use commercially reasonable efforts to procure such component; (y) notwithstanding any volume commitment of Customer, any supply commitment by Leiters, or any provision of these Conditions or any Contract or Special Terms, in no event does or shall Leiters guarantee or be understood or deemed to have guaranteed the supply or availability of such component from any manufacturer, distributor, or other supplier thereof; and (z) provided that Leiters has used its commercially reasonable efforts in good faith as provided in the foregoing clause (x), Leiters shall have no liability for any failure or inability to Supply that results, directly or indirectly, in whole or in part, from the failure, refusal, or inability of any such manufacturer, distributor, or other supplier of such component to supply the same to Leiters (and, in that case, Leiters and Customer shall cooperate in good faith and use commercially reasonable efforts to work together on alternative means to obtain such component, including but not limited to as contemplated by the first sentence of this Section 3). Notwithstanding any provision of these Conditions or any Contract or Special Terms, Leiters reserves the right to pass through to Customer any increase in Leiters’ cost to procure any component of compounding, repackaging, or other Supply services that is itself an approved finished human drug product.
4. PURCHASE ORDERS. Customer is responsible for: (a) the accuracy of the terms in any order; (b) where applicable, ensuring that any Specifications in any quotation from Leiters are complete and correct and/or meet the requirements of Customer; and (c) giving Leiters accurate, complete and correct information relating to Customer’s requirements for the Supply of Product(s). Each order submitted by Customer shall be deemed to incorporate these Conditions, shall comply with all Applicable Laws, shall be signed by Customer, and shall specify the quantity of each Product to be Supplied, the destination, the price and delivery date, and such other information necessary to effect delivery of each Product. NO ADDITIONAL PRE-PRINTED TERMS OR CONDITIONS CONTAINED IN EITHER PARTY’S PURCHASE ORDERS, ORDER CONFIRMATIONS, INVOICES, QUOTATIONS OR ANY OTHER FORMS SHALL APPLY.
5. DELIVERY. Leiters shall deliver Product to Customer FOB the Facility. Except as otherwise provided in Writing or an applicable Leiters promotion, Customer shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping Product from the Facility to Customer’s designated location. Title to and all risk of loss of or damage to Product shall pass to Customer upon delivery. Any dates quoted or agreed for delivery of Product are approximate only (except pursuant to an order submitted and accepted at least thirty (30) days prior to the requested delivery date or unless otherwise agreed in Writing), and Leiters shall not be liable for any delay in delivery caused by events or circumstances beyond Leiters’ reasonable control.
6. INSPECTION, ACCEPTANCE, AND REJECTION OF PRODUCTS. Customer will have 48 hours from delivery to inspect Products (the “Inspection Period”). Any Product not compliant with the Specifications or Applicable Laws shall be deemed a “Defective Product”. If Customer intends to reject Products because such Products are Defective Products, it shall give notice in Writing within 24 hours after the Inspection Period expires; otherwise, Products shall be deemed accepted and may not be returned for any reason. Leiters will, at Customer’s option, either promptly replace at its cost any Defective Product or credit or refund any payments made by Customer for such Defective Product.
7. INVOICES. Leiters shall invoice Customer upon delivery as provided above. Customer shall pay the amount of each invoice within thirty (30) days of the date of invoice (with interest on past due amounts at the rate of 1.5% per month). Payment will be credited when the funds paid are available to Leiters without any restriction relating to the collectability of the funds received from Customer. Surcharges may apply if Customer pays by credit card. If at any time, in Leiters’ sole discretion, Customer’s credit is impaired, Leiters shall have the right to require payment in advance before making any further shipment of Products. If Customer shall fail, within a reasonable time, to make such payment in advance, or if Customer shall fail to make payment when due, Leiters shall have the right, at its option, to suspend further deliveries hereunder until such failure is corrected, without thereby releasing Customer from its obligations under the Contract.
8. FAILURE TO TAKE DELIVERY. If Customer fails or refuses to take delivery, Customer shall be billed at that time for all unshipped Product, and on the first of each month thereafter for reasonable administration and storage costs. For each such shipment of undelivered Product, Customer agrees that: (a) Customer has made a fixed commitment to purchase such Product; (b) risk of ownership for such Product shall be borne by Customer; (c) such Product shall be on a bill-and-hold basis for legitimate business purposes; and (d) if no delivery date is determined at the time of billing, Leiters shall have the right to ship such Product at or after billing.
9. RECALLS. In the event that a recall, withdrawal or field correction of any Product (a “Recall”) is initiated, whether by a statutory or Regulatory Authority in any jurisdiction (including the FDA, state boards of pharmacy, and state controlled substance boards), Leiters shall comply with all requirements of such statutory or Regulatory Authority with respect to such Recall (provided that Customer shall reasonably cooperate with Leiters in connection with any Recall).
10. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other Party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the state in which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such Party has and will continue to have the power and authority and the legal right to enter into the Contract and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Contract and the performance of its obligations thereunder; (c) the Contract has been duly executed and delivered on behalf of such Party and constitutes the legal, valid, and binding obligation of such Party enforceable against such Party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such Party in connection with the execution, delivery, and performance of the Contract by such Party have been obtained; and (e) the execution and delivery of the Contract by such Party, the exercise by such Party of its rights thereunder, and the performance by such Party of its obligations thereunder do not and will not contravene or conflict with such Party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.
11. REPRESENTATIONS AND WARRANTIES OF LEITERS. Leiters hereby represents, warrants and covenants as follows: (a) Leiters has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary to Supply the Product(s) in compliance with Applicable Laws; (b) all Product(s) delivered to Customer hereunder shall have been Supplied by Leiters in compliance with these Conditions, the Specifications, cGMP, and all Applicable Laws; and (c) Leiters has and will convey to Customer good title to all Product(s), free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever. In furtherance of the foregoing clause (b), if Customer submits an order for a Product that does not appear on the drug shortage list in effect under Section 506E of the Act at the time of Supply or the time of dispensing by Customer, and of which the bulk drug substance is also a component of an FDA-approved drug or a Covered OTC Drug Product (as defined below), such that Leiters reasonably believes that it is required by Applicable Law to obtain an assurance, either from Customer or its prescribing health care practitioner, to the effect that such Product will be administered or dispensed only to patients for whom the change between the Product and the FDA-approved drug (or Covered OTC Drug Product) produces a clinical difference, as determined by such prescribing health care practitioner, Customer agrees that it will provide (and will be able to provide on behalf of such prescribing health care practitioner) such assurance in writing either on the order form for such Product or promptly following Leiters’ request. For this purpose, “Covered OTC Drug Product” means any marketed drug not subject to Section 503(b) of the Act (i.e., non-prescription drugs) and not subject to approval in an application submitted under Section 505 of the Act.
12. REPRESENTATIONS AND WARRANTIES OF CUSTOMER. Customer hereby represents, warrants, and covenants to Leiters as follows: (a) Customer has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary to order, possess, prescribe, administer, dispense, and/or dispose of the Product(s), as applicable, in compliance with Applicable Laws and shall order, possess, prescribe, administer, dispense, dispose of, and otherwise use the Product(s) properly, in compliance with Applicable Laws, and in conformity with sound professional medical practice and judgment; (b) Customer shall not engage in any sale or transfer of any Product in violation of the “own use” restrictions set forth in Section 503B(a)(8) of the Act (21 U.S.C. 353b(a)(8)); (c) with respect to any order for repackaging of a drug product, the drug product to be repackaged is an Eligible Prescription Drug Product; (d) with respect to any order for mixing, diluting, or repackaging of a biological product, the biological product to be mixed, diluted, or repackaged is an Eligible Biological Product; and (e) Customer has and shall maintain in full force and effect insurance coverages (including carriers of such insurance) that are reasonable, appropriate, and sufficient for the business of Customer and the risks of its business and operations and shall provide to Leiters, promptly upon Leiters’ request, a certificate or other satisfactory proof evidencing such insurance (which certificate, if reasonably requested by Leiters, shall also name Leiters as an additional insured).
13. LIMITATIONS. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THE FOREGOING SECTIONS 10, 11, and 12 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES, OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.
14. INDEMNIFICATION. Each of Leiters and Customer (in either case, the “Indemnifying Party”) shall indemnify and hold harmless the other Party and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from: (a) any misrepresentation or breach of warranty made by the Indemnifying Party in the Contract; (b) any breach of any covenant or agreement made or to be performed by the Indemnifying Party pursuant to this Contract; or (c) the negligence or willful misconduct of the Indemnifying Party; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract. Without limiting the generality of the foregoing, Customer, as the Indemnifying Party, shall indemnify and hold harmless the Leiters Indemnified Parties from and against any and all Losses arising from or in connection with any Claim suffered or incurred by any Leiters Indemnified Party arising out of or resulting from the possession, prescription, administration, dispensing, disposal, or other use of any Product that is Supplied by Leiters hereunder in compliance with cGMP and Applicable Laws.
15. LIMITATIONS OF LIABILITY. (A) LEITERS’ TOTAL LIABILITY TO CUSTOMER, WHETHER IN CONTRACT OR TORT, SHALL IN NO EVENT EXCEED THE TOTAL PRICE PAID BY CUSTOMER TO LEITERS PURSUANT TO THE ORDER RELATING TO THE SUPPLY OF PRODUCT GIVING RISE TO THE CLAIM. (B) EXCEPT WITH RESPECT TO PERSONALLY IDENTIFIABLE INFORMATION, A PARTY’S FRAUD, OR DEATH OR PERSONAL INJURY CAUSED BY SUCH PARTY’S NEGLIGENCE, IN ANY DISPUTE ARISING OUT OF THE CONTRACT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR TO ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, EXEMPLARY, INDIRECT, INCIDENTAL, CONSE-QUENTIAL OR PUNITIVE DAMAGES OF ANY KIND OR NATURE WHATSOEVER (INCLUDING, WITHOUT LIMITATION, LOST REVENUES, PROFITS, SAVINGS OR BUSINESS, OR LOSS OF RECORDS OR DATA), WHETHER IN AN ACTION BASED ON CONTRACT, WARRANTY, STRICT LIABILITY, TORT (INCLUDING, WITHOUT LIMITATION, NEGLIGENCE) OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES AND EVEN IF SUCH DAMAGES COULD HAVE BEEN REASONABLY FORESEEN BY ANY PARTY, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
16. TERMINATION. Unless otherwise agreed in Writing: (a) a Party may immediately terminate the Contract by written notice if the other Party materially breaches any provision of the Contract and such breach is not cured within thirty (30) calendar days after receipt of Written notice identifying such breach; (b) a Party may immediately terminate the Contract by Written notice if the other Party has been unable to perform its obligations for ninety (90) consecutive calendar days by reason of Force Majeure; (c) a Party may immediately terminate the Contract by Written notice in the event that (i) a bankruptcy petition is filed against the other Party or a receiver, trustee, or other custodian is appointed for all or any substantial portion of the assets or business of the other Party that is not dismissed within thirty (30) days from the date of such filing or appointment; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; (iii) the other Party suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days; or (iv) such other Party enters into an agreement with its creditors or makes an assignment for the benefit of creditors; and (d) Leiters may terminate the Contract upon ninety (90) days Written notice to Customer (or, if such termination is, in Leiters’ sole discretion, necessitated by a Regulatory Change (as defined below), then upon thirty (30) days Written notice to Customer or less to the extent necessary for Leiters to comply with such Regulatory Change). The term “Regulatory Change” means any change in Applicable Laws that makes or is reasonably likely to make Leiters’ performance of its obligations under the Contract (or any portion thereof), or the manner in which Leiters performs or is to perform such obligations, unlawful.
17. CONFIDENTIALITY. (a) Customer shall not use Confidential Information for any purpose other than to the limited extent necessary to carry out the Contract, shall protect Confidential Information with the same degree of security afforded Customer’s own proprietary information and, in all events, with reasonable care, and shall not disclose Confidential Information to any third party (except that Customer may disclose Confidential Information upon receipt of specific prior written consent from Leiters or if Customer is legally compelled to disclose the Confidential Information and Customer provides reasonable advance notice to Leiters). (b) The obligations created by the foregoing clause (a) shall not apply to particular Confidential Information if Customer can reasonably demonstrate such Confidential Information is in the public domain at the time of disclosure thereof by Leiters to Customer, becomes publicly available subsequent to disclosure thereof by Leiters without Customer’s breach of any obligations owed to Leiters, became known by Customer at any time from a source other than Leiters and other than by breach of an obligation of confidentiality owed to Leiters, was otherwise known by Customer prior to disclosure thereof by Leiters to Customer, or was independently developed by Customer without reference to, exposure to, use of, or disclosure of any Confidential Information. (c) Following performance or termination of the Contract, Customer shall, upon request, promptly return or destroy all tangible items in its possession containing Confidential Information, delete all electronic media containing Confidential Information, and (if requested) certify to Leiters in writing that it has complied with the obligations of this clause (c) (provided that, for the sole purpose of evidencing compliance with this Section, Customer may maintain a secure file containing a single copy of all items returned to Leiters). (d) If Customer breaches this Section, then Leiters shall, without being required to demonstrate damage or irreparable harm, be entitled to a temporary restraining order, preliminary and permanent injunction, specific performance and other equitable relief as necessary to enjoin or equitably remedy the conduct in breach, and the availability or election of equitable remedies shall be in addition and without prejudice to any other remedies available to Leiters. (e) This Section does not grant any license or transfer any property interest to Customer or obligate Leiters to disclose any Confidential Information to Customer. (f) Obligations created by this Section shall survive the performance or termination of the Contract for a period of five years.
18. ASSIGNMENT. Leiters may assign the Contract or any part of it, or subcontract any of its obligations under the Contract, to any person, firm or entity (including, by way of illustration and not limitation, to a Leiters Affiliate operating a Facility at which a Customer order may be filled). Customer shall not be entitled to assign the Contract or any part of it without the prior written consent of Leiters.
19. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.
20. WAIVER. No delay on the part of Leiters or Customer in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Contract may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.
other right, power or privilege hereunder. Any provision of the Contract may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.
21. SEVERABILITY. If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of these Conditions and the remainder of the provision in question shall not be affected thereby.
22. ENTIRE AGREEMENT. The Contract constitutes the entire agreement between the Parties with respect to the subject matter thereof and supersedes all prior agreements, understandings and negotiations, both written and oral, between the Parties with respect to the subject matter of the Contract.
23. GOVERNING LAW. The Contract shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.
24. FORCE MAJEURE. Neither Party will be liable to the other for any failure or delay in performance (other than such Party’s payment obligations hereunder) if the failure or delay is due to an act of God, war, riot, revolution, fire, explosion, sabotage, terrorism, accident, casualty, or other cause not within the reasonable control of the Party claiming a Force Majeure situation. Without limiting the generality of the foregoing, “Force Majeure” with respect to Leiters shall include shortage or unavailability of supply of drug products or active pharmaceutical ingredients resulting from any of the foregoing occurrences and/or similar events of equal magnitude otherwise outside of Leiters’ reasonable control.
25. DEFINITIONS. As used herein: (a) “Act” means the U.S. Food, Drug, and Cosmetic Act, as amended; (b) “Affiliate” of a party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (c) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, statutes, codes, ordinances, rules and regulations, and interpretations of any agency, government, authority, commission, board, bureau, or administrative or other entity, body, or Regulatory Authority (including without limitation any then-most-current FDA guidance documents) that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (d) “cGMP” means FDA’s current Good Manufacturing Practices as promulgated under the Act at 21 CFR (parts 210 and 211), and as further defined by then-most-current FDA guidance documents, in each case as applicable to the compounding, manufacture, packaging, handling and storage of Product(s); (e) “Conditions” means these Standard Terms and Conditions for the Supply of 503B Products and Services; (f) “Confidential Information” means Leiters’ information regarding its products, business and technology that is not readily available to the public, whether in tangible or intangible form, including but not limited to market information, prices and pricing structure, in-depth product and process knowledge, trade secrets, supplier and customer information, technical data and specifications; contractual relationships; business methods; market data; financial data; projections; strategies; intellectual property rights, including trademarks, patents and copyrights; and the Contract; in each case which is not generally available or disclosed to the public or which is marked or labeled “Proprietary and Confidential”; (g) “Contract” means an agreement in Writing between Customer and Leiters pursuant to which Leiters Supplies Product(s) to Customer in accordance with these Conditions and any Special Terms; (h) “Eligible Biological Product” means a biological product that is eligible under Applicable Law (including any then-most-current FDA guidance documents) to be mixed, diluted, or repackaged by an FDA-registered 503B outsourcing facility; (i) “Eligible Prescription Drug Product” means a prescription drug product that is eligible under Applicable Law (including any then-most-current FDA guidance documents) to be repackaged by an FDA-registered 503B outsourcing facility; (j) “Facility” means and refers to any FDA-registered 503B outsourcing facility operated by Leiters or any of its Affiliates, including without limitation such facility registered in the name of Denver Solutions, LLC d.b.a. Leiters Health and located at 13796 Compark Boulevard, Englewood, Colorado 80112; (k) “FDA” means the U.S. Food and Drug Administration; (l) “Leiters” means Denver Solutions, LLC, a Delaware limited liability company d.b.a. Leiters Health; (m) “Product” means the drug preparation, product, or related service (or any combination thereof) that is the subject of a Leiters quotation and/or Customer order, as contemplated by these Conditions; (n) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, compounding, packaging, repackaging, manufacture, use, storage, import, promotion, marketing and sale of a Product in a country; (o) “Special Terms” means any special terms and conditions of the Contract agreed in Writing by Customer and Leiters; (p) “Specifications” means Customer’s specifications for the Product(s) set forth in the applicable order (or in a Leiters quotation upon which such order is based); (q) “Supply” means the compounding, manufacturing, packaging, repackaging, labeling, quality control, testing, preparing for shipment and selling of Products; and (r) “Writing” means any written communication (including fax and e-mail) between Leiters and Customer.